Legal

Biosimilars: considerations in light of the Italian legal framework

Published in: Volume 8 / Year 2019 / Issue 1
Author(s): ,
Page: 5-23

Abstract: Biological and biotechnological medicines are important pharmaceutical innovations due to their influence on the treatment of many conditions and because they have led the way in devising new and… Read More »

Biosimilars patent litigation in Canada and Japan: a comparative strategic overview and EU and US update

Published in: Volume 5 / Year 2016 / Issue 2
Author(s): ,
Page: 60-5

Abstract: Biosimilars are highly similar versions of reference biological products, some with the potential to be deemed ‘interchangeable’ by medicines regulatory bodies, such as the US Food and Drug Administration.… Read More »

It is time to change US trade policy to foster access to medicines

Published in: Volume 9 / Year 2020 / Issue 1
Author(s):

Abstract: While Americans are deeply concerned about drug prices, the United States Trade Representative (USTR) continues to negotiate agreements like the United States-Mexico-Canada Agreement (USMCA) that put at risk the… Read More »

Policy recommendations for a sustainable biosimilars market: lessons from Europe

Published in: Volume 9 / Year 2020 / Issue 2
Author(s): ,

Abstract: Approximately 25% of all new medicines approved in recent years and in development today are biologicals. The complexity of biologicals, the investment needed to meet ever more stringent regulatory… Read More »

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